EUCTR2014-004850-32-ES进行中（未招募）1 期
A 26-week open-label study assessing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination in adults with Type 2 Diabetes inadequately controlled on GLP-1 receptor agonist and metformin ± pioglitazone - LixiLan-G
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 770
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Patients with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.
- •-Patients who have been treated with one of the following glucagon-like peptide 1 (GLP-1) receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1):
- •-Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if the 1.8 mg QD dose is not well tolerated according to the Investigator's judgment or
- •-Exenatide (Byetta®) 10 ?g BID or of 5 ?g BID, if 10 ?g BID dose is not well tolerated according to the Investigator's judgment in combination with metformin (daily dose ?1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, both at stable dose for at least 3 months prior to screening.
- •Patients who have been treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
- •-Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator?s judgment,
- •-Albiglutide (Tanzeum®, Eperzan®) 50 mg QW or 30 mg QW, if 50 mg QW is not well tolerated according to Investigator?s judgment,
- •-Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator?s judgment in combination with metformin (daily dose ?1500 mg/day or MTD), with or without pioglitazone, both at stable dose for at least 3 months prior to screening;
- •-Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 616
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
排除标准
- •-At screening visit, age <18.
- •-Screening HbA1c <7% and >9%.
- •-Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
- •-Any use of oral antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.
- •-Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [?10 days] due to intercurrent illness including gestational diabetes is allowed at the discretion of the study physician).
- •-Laboratory findings at the time of screening, including:
- •-Fasting plasma glucose (FPG) >250 mg/dL (13.9 mmol/L),
- •-Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
- •-Alanine transaminase or aspartate transaminase >3 ULN,
- •-Calcitonin ?20 pg/mL (5.9 pmol/L),
- •-Positive pregnancy test.
- •-Patient who has renal function impairment with estimated glomerular filtration rate <30 mL/min (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.
- •-Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum®/Eperzan® or Trulicity®) according to local labeling.
- •-Any contraindication to metformin or pioglitazone use, according to local labeling.
- •-History of hypersensitivity to insulin glargine, or to any of the excipients.
- •-History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
- •-Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
- •-History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
- •-Body mass index ?20 or >40 kg/m^2.
研究者
相似试验
进行中（未招募）
1 期
A 20-week open-label study to assess the efficacy and safety of single doses of Ilaris® (Canakinumab, ACZ885) in patients with active, refractory urticarial vasculitis” - ILUVITrticarial vasculitisMedDRA version: 12.1Level: LLTClassification code 10048820Term: Urticarial vasculitisEUCTR2010-020063-21-DECharité-Universitätsmedizin10
进行中（未招募）
1 期
Efficacy study to evaluate fluticasone furoate /vilanterol Inhalation Powder delivered once daily via the Dry Powder Inhaler Ellipta™ compared with usual ICS/LABA maintenance therapy delivered by Dry Powder Inhaler in subjects with Persistent AsthmaSubject with persistent asthmaMedDRA version: 19.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-000551-81-DEGlaxoSmithKline Research & Development Limited422
进行中（未招募）
不适用
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With SchizophreniaMedDRA version: 16.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2012-002785-12-EEH. Lundbeck A/S286
进行中（未招募）
不适用
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With SchizophreniaMedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2012-002785-12-CZH. Lundbeck A/S286
进行中（未招募）
不适用
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With SchizophreniaSchizophreniaEUCTR2012-002785-12-DEH. Lundbeck A/S286